Vitamin-D Insufficiency and Implants

NCT06452251 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2024-07-16

No results posted yet for this study

Summary

Vitamin D is important for bone health, immune function, and inflammation, along with dental implant success. The study aimed to assess bone markers and cytokine levels in patients with and without vitamin D insufficiency to better understand the effects of vitamin D levels on dental implant integration. The study included 42 patients in 2 groups; with insufficient (Group IN-S; n=21) and sufficient (Group S; n=21) levels of vitamin D. Bone remodelling, proinflammatory and antiinflammatory markers were analyzed in bone and peri-implant crevicular fluid (PICF) using enzyme-linked immunosorbent assay (ELISA) and results were reported as concentration and total amount.

Conditions

  • Vitamin D Deficiency
  • Osseointegration Failure of Dental Implant
  • Peri-Implantitis

Interventions

DIAGNOSTIC_TEST

OPG, OC, RANKL, IL-10, IL-1β, Ca, TNF-α and Caspase-1 ELISA

The levels of OPG, OC, RANKL, IL10, IL1β, Ca, TNF-α and Caspase1 in bone and PICF of patients with or without Vitamin D sufficiency were measured by ELISA.

DIAGNOSTIC_TEST

Resonance Frequency Analysis

Implant stability was measured by a device (Penguin RFA, Integration Diagnostics, Sweden) based on Resonance Frequency Analysis (RFA) and categorized by Implant Stability Quotient (ISQ) scale.

DIAGNOSTIC_TEST

Periodontal clinical examination

Clinical periodontal indices including plaque index (PI) (Silness and Löe 1964), gingival index (GI) (Löe 1967), probing depth (PD), and bleeding on probing (BOP) (Ainamo and Bay 1975) were recorded using a Williams periodontal probe. The BOP percentage (%) was calculated by dividing the number of bleeding sites by the total number of sites examined.

PROCEDURE

Dental implant placement and bone sample collection

All patients were received by a single examiner a bone level implant (standard type and Sandblasted, Large-grit, Acid-etched surface) (Implant Swiss, Yverdon, Switzerland).

PROCEDURE

Gingival Crevicular Fluid Sampling

One month after the healing caps were inserted, peri-implant crevicular fluid (PISF) samples were collected from 6 different sides of each implant. Before sampling, the area was isolated and dried, and paper strips were gently kept in periimplant sulcus for 30 seconds. Strips with blood or saliva contamination were discarded. PISF volumes of each strip were measured by a device (Periotron 8,010, Oraflow Inc, USA). Strips were then pooled, and inserted into tubes. PISF was recovered from paper strips through agitation in phosphate buffer saline (50 mM Tris-HCl, 5 mM CaCl2, 0.2 M NaCl,pH 7.5). All samples were stored at -80C until the day of analysis.

Sponsors & Collaborators

  • Inonu University

    collaborator OTHER
  • Vesile Elif Toy

    lead OTHER

Principal Investigators

  • Vesile E Toy, Phd · Inonu University

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-06-01
Completion
2023-10-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06452251 on ClinicalTrials.gov